Status:
COMPLETED
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Medrio, Inc
SAS Institute
Conditions:
Digestion
Gut Microbiota
Eligibility:
All Genders
3-28 years
Phase:
NA
Brief Summary
This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of he...
Detailed Description
Breastmilk contains an abundance of structurally diverse compounds having important physiologic roles. These include glycoproteins which are biologically active and involved in infant gut, immune and ...
Eligibility Criteria
Inclusion
- Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
- Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
- Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
- Infants whose parent(s)/LAR have a working freezer.
- Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:
- Healthy term infant (37-42 weeks of gestation).
- At enrolment visit, post-natal age 3-28 days (date of birth = day 0)
- Birth weight ≥ 2500g and ≤ 4500g.
- Formula-fed infants only: Infants must predominantly consume and tolerate a standard cow's milk infant formula prior to enrolment and their parent(s)/LAR must have independently elected, before enrolment, not to exclusively breastfeed. Predominantly formula feeding means that the infant's predominant source of nourishment has been formula. Specifically, infants are fed with formula for at least 75% of total milk feeds per day.
- Breastfed infants only: Infants must have been predominantly breastfed since birth, and their parent(s)/LAR must have made the decision to continue predominant breastfeeding for the duration of the study. Predominant breastfeeding allows infants to be mix fed with breastmilk and other milks. It means that the infant's predominant source of nourishment has been breastmilk. Specifically, infants are fed with breast milk for at least 75% of total milk feeds per day.
Exclusion
- Infants with conditions requiring infant feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
- Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- Documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
- Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study.
- Infants who are presently receiving or have received prior to enrollment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and microbiota (e.g., oral and systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
- Currently participating or having participated in another clinical trial since birth.
- Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol.
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04880083
Start Date
July 9 2021
End Date
December 28 2022
Last Update
July 2 2025
Active Locations (1)
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1
Shanghai Public Health Clinical Center
Shanghai, China